Imported medical devices are classified into three categories:

Class II refers to medical devices whose safety and effectiveness require control; Class III refers to medical devices that pose potential risks to human body and whose effectiveness must be strictly controlled.

First, companies importing medical equipment need a Medical Device License, Business License,

Authorization, Medical Device Registration Certificate and Medical Device Filing Certificate.import and exportDocuments required for importing medical devices include:

Imported Medical Device Registration Certificate and Medical Device Registration Certificate issued by the National Medical Products Administration;

Medical devices in the compulsory certification catalog require China Compulsory Certification (CCC);

Some equipment requires Automatic Import License;

Equipment photos, technical parameter nameplates, and final Chinese instruction manuals;

Packing list, contract, invoice, etc.

Packing list, contract, invoice, etc.

Customs clearance process: Port arrival - Bill of exchange - Customs declaration - Inspection - Customs valuation and taxation - Tax payment - Customs inspection - Cargo release - Pickup - Delivery

Imported medical equipment may be exempt from taxes, but only instruments and equipment imported by non-profit medical research and teaching institutions qualify for tax exemption;

Imported medical devices must be brand new. The import of expired, time-sensitive, or used medical devices such as obsolete equipment is strictly prohibited.

The validity period of a medical device registration certificate is 5 years. An application for renewal must be submitted to the original registration department 6 months in advance.

Transportation must comply with the requirements specified in the medical device instructions and labels, including temperature control. For devices with special environmental requirements such as humidity, corresponding measures must be taken to ensure the safety and effectiveness of the medical devices. If packaging is compressed or damaged due to moisture, affecting the usability of the contents, customs will legally return or destroy the goods to effectively protect the lives, health, and safety of Chinese customers.

Imported goods cannot be sold or used without passing inspection by the destination customs. Violators will have their goods confiscated.